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PubMed2003

Balloon angioplasty versus medical therapy for hypertensive patients with renal artery obstruction.

BACKGROUND: Atherosclerotic renal artery stenosis is the most common cause of secondary hypertension. Balloon angioplasty is widely used for the treatment of hypertensive patients with renal artery stenosis. OBJECTIVES: The objective of this systematic review was to compare the effectiveness of balloon angioplasty (with and without stenting) with medical therapy on blood pressure control, renal function, frequency of renovascular complications, and side effects in hypertensive patients with atherosclerotic renal artery stenosis. SEARCH STRATEGY: The reviewers performed a search of MEDLINE from 1966 to December 2002, EMBASE from 1980 to 2002, Science Citation Index from 1990 to 2002, the Cochrane Central Register of Controlled Trials and personal files to identify randomised controlled trials comparing balloon angioplasty with medical therapy in hypertensive patients with renal artery stenosis. In addition, reference lists of papers resulting from this search were hand-searched, and authors of published trials were contacted to enquire if they were aware of any eligible unpublished trials. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials comparing balloon angioplasty with medical therapy in hypertensive patients with haemodynamically significant renal artery stenosis (greater than 50 per cent reduction in luminal diameter and minimal follow-up of six months). DATA COLLECTION AND ANALYSIS: Two investigators independently extracted data on trial design, characteristics of trial participants, types of interventions, and outcome measures. The quality of the available data precluded a formal meta-analysis to assess the effect on blood pressure, renal function, and number and defined daily doses of antihypertensive drugs. Peto's odds ratios and corresponding 95% confidence intervals (CI) were calculated for dichotomous outcomes such as the presence or absence of patent vessels and renovascular complications. MAIN RESULTS: Three randomised controlled trials involving 210 patients met the inclusion criteria. In unselected patients there was a consistent, but statistically non significant trend towards lower blood pressure in the balloon angioplasty group. Patients treated with balloon angioplasty required less antihypertensive drugs in two of three trials, and were more likely to have patent renal arteries after 12 months (OR 4.2, 95% CI 1.8 to 9.8). There were no differences in renal function. There were significantly fewer cardiovascular and renovascular complications in patients treated with angioplasty (OR 0.32, 95% CI 0.15 to 0.70, test for heterogeneity p > 0.1). REVIEWER'S CONCLUSIONS: Available data are insufficient to conclude that balloon angioplasty is superior to medical therapy in lowering blood pressure of patients with renal artery stenosis in whom blood pressure can be controlled with medical therapy. In patients with hypertension refractory to medical therapy, there is some weak evidence that balloon angioplasty lowers blood pressure more effectively than medical therapy. Balloon angioplasty appears to be safe and leads to fewer cardiovascular and renovascular complications. There is a need for randomised controlled trials comparing the effect of balloon angioplasty and medical therapy on the preservation of renal function in the long term.

Angioplasty, Balloon↗
PubMed2002

Vaginal disinfection during labour for reducing the risk of mother-to-child transmission of HIV infection.

BACKGROUND: Mother-to-child transmission (MTCT) of HIV infection is one of the most tragic consequences of the HIV epidemic, especially in resource-limited countries, resulting in about 650 000 new paediatric HIV infections each year world-wide. The paediatric HIV epidemic threatens to seriously undermine decade-old child survival programmes. This is one of several reviews assessing the available evidence for preventing HIV transmission from an HIV-infected woman to her child. The other reviews assess the effects of antiretroviral therapy, Caesarean section delivery, breast feeding, and vitamin A supplementation. OBJECTIVES: To estimate the effect of vaginal lavage on the risk of MTCT of HIV and infant and maternal mortality and morbidity, as well as tolerability of vaginal lavage in HIV infected women. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, Cochrane Pregnancy and Childbirth Register, PubMed, EMBASE, AIDSLINE, LILACS, AIDSTRIALS, and AIDSDRUGS, using standardised methodological filters for identifying trials. We also searched reference lists of identified articles, relevant editorials, expert opinions and letters to journal editors, and abstracts and proceedings of relevant conferences, and contacted subject experts and pharmaceutical companies. There were no language restrictions. SELECTION CRITERIA: Randomised trials or clinical trials comparing vaginal disinfection during labour with placebo or no treatment, in known HIV infected pregnant women. Trials had to include an estimate of the effect of vaginal disinfection on MTCT of HIV and/or any other pre-specified adverse pregnancy outcome to be included. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial eligibility and quality, and extracted data. MAIN RESULTS: Only one low quality trial included an estimate of the effect of vaginal disinfection on at least one pre-specified outcome. There was no evidence of an effect of vaginal disinfection on MTCT of HIV (odds ratio 0.93, 95% confidence interval 0.63 to 1.38), and no information was available on the other pre-specified outcomes. REVIEWER'S CONCLUSIONS: There is a need for well-designed randomised controlled trials to estimate the effects of vaginal disinfection on MTCT of HIV.

Disinfection↗
PubMed2006

Tongxinluo (Tong xin luo or Tong-xin-luo) capsule for unstable angina pectoris.

BACKGROUND: Tongxinluo capsule is a medicine consisting of traditional Chinese herbs and insects used for cardiovascular diseases in China and some other Asian countries. To date the evidence of its effect has not previously been subject to systematic review, making it difficult to derive robust conclusions about its actual benefits, and indeed, possible harms. OBJECTIVES: To assess systematically the effects of tongxinluo capsule in people with unstable angina pectoris. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library, Issue 4 2004, MEDLINE, EMBASE, Chinese Biomedical Database, China National Knowledge Infrastructure, Japana Centra Revuo Medicina (all 1995 to 2005). We also handsearched the relevant Chinese journals, checked with manufacturers and registers of ongoing studies. SELECTION CRITERIA: Randomised trials comparing either tongxinluo capsule only or standard treatment plus tongxinluo capsule with standard treatment or other anti-angina pectoris drugs, placebo or no intervention. DATA COLLECTION AND ANALYSIS: Two authors identified relevant studies for the review independently and went on to abstract data, and assess trial quality. Authors of included studies were contacted to obtain further information as required. MAIN RESULTS: 18 short term follow-up trials involving 1413 people were included. The studies did not provide strong support of a benefit of tongxinluo for reducing the combined outcome of acute myocardial infarction, angioplasty (PTCA) coronary artery bypass graft (CABG) and sudden death or all-cause mortality (RR 0.42, 95% CI 0.07 to 2.59, P=0.35; RR 0.33, 95% CI 0.01to 7.78, P=0.49, respectively). Tongxinluo reduced the frequency of acute angina attacks (WMD -1.20, 95%CI -1.38 to -1.02, P<0.00001 and RR -2.36, 95%CI -2.53 to -2.18, P<0.00001, respectively), improved ECG (RR 1.31, 95% CI 1.08 to 1.57, P=0.005) and angina symptoms (RR 1.21, 95% CI 1.06 to 1.40; P=0.007). AUTHORS' CONCLUSIONS: Tongxinluo in combination with routine angina therapy appears to reduce the risk of subsequent AMI, PTCA or CABG, angina attacks and severity, as well as improving symptoms and ischaemic changes on the electrocardiogram (ECG). Due to the methodological limitations of the studies, the evidence is insufficient to make any conclusive recommendations about the use of this treatment for patients presenting with unstable angina. Large high quality randomised controlled trials are warranted.

Angina, Unstable↗
PubMed2002

Long-term effects of mammography screening: updated overview of the Swedish randomised trials.

BACKGROUND: There has been much debate about the value of screening mammography. Here we update the overview of the Swedish randomised controlled trials on mammography screening up to and including 1996. The Kopparberg part of the Two-County trial was not available for the overview, but the continuation of the Malmö trial (MMST II) has been added. The article also contains basic data from the trials that have not been presented before. Methods The trials (n=247010, invited group 129750, control group 117260) have been followed up by record linkage to the Swedish Cancer and Cause of Death Registers. The relative risks (RR) for breast cancer death and mortality were calculated for the invited and the control groups. The trial-specific as well as the age-specific effects were analysed. RRs were calculated by the density method, with total person-time experience of the cohort by time interval of follow-up as a basis for estimating mortality rates. We calculated weighted RRs and 95% CI with the Mantel-Haenszel procedure. FINDINGS: The median trial time-the time from randomisation until the first round was completed for the control group or if the control group was not invited, until end of follow-up-was 6.5 years (range 3.0-18.1). The median follow-up time, the time from randomisation, to the end of follow-up, was 15.8 years (5.8-20.2). There were 511 breast cancer deaths in 1864770 women-years in the invited groups and 584 breast cancer deaths in 1688440 women-years in the control groups, a significant 21% reduction in breast cancer mortality (RR=0.79, 95% CI 0.70-0.89). The reduction was greatest in the age group 60-69 years at entry (33%). Looking at 5-year age groups, there were statistically significant effects in the age groups 55-59, 60-64, and 65-69 years (RR=0.76, 0.68, and 0.69, respectively). There was a small effect in women 50-54 years at randomisation (RR=0.95). The benefit in terms of cumulative breast cancer mortality started to emerge at about 4 years after randomisation and continued to increase to about 10 years. Thereafter the benefit in absolute terms was maintained throughout the period of observation. The age-adjusted relative risk for the total mortality was 0.98 (0.96-1.00). INTERPRETATION: The advantageous effect of breast screening on breast cancer mortality persists after long-term follow-up. The recent criticism against the Swedish randomised controlled trials is misleading and scientifically unfounded.

Adult↗
PubMed2006

Effect of oral contraceptives and hormone replacement therapy on bone mineral density in premenopausal and perimenopausal women: a systematic review.

Seventy five articles on the effect of oral contraceptives and other hormone replacement on bone density in premenopausal and perimenopausal women were reviewed. The evidence was appraised using the Oxford Centre for Evidence-Based Medicine levels of evidence. There is good evidence for a positive effect of oral contraceptives on bone density in perimenopausal women, and fair evidence for a positive effect in "hypothalamic" oligo/amenorrhoeic premenopausal women. There is limited evidence for a positive effect in healthy and anorexic premenopausal women. In hypothalamic oligo/amenorrhoeic women, baseline bone density has been shown to be significantly lower than that in healthy controls, therefore the decision to treat is clinically more important. The ideal formulation(s) and duration of treatment remain to be determined by further longitudinal and prospective randomised controlled trials in larger subject populations.

Absorptiometry, Photon↗
PubMed2003

Prophylactic respiratory physiotherapy after cardiac surgery: systematic review.

OBJECTIVE: To assess whether respiratory physiotherapy prevents pulmonary complications after cardiac surgery. DATA SOURCES: Searches through Medline, Embase, Cinahl, the Cochrane library, and bibliographies, for randomised trials comparing any type of prophylactic respiratory physiotherapy with another type or no intervention after cardiac surgery, with a follow up of at least two days, and reporting on respiratory outcomes. REVIEW METHODS: Investigators assessed trial validity independently. Information on study design, population, interventions, and end points was abstracted by one investigator and checked by the others. RESULTS: 18 trials (1457 patients) were identified. Most were of low quality. They tested physical therapy (13 trials), incentive spirometry (eight), continuous positive airway pressure (five), and intermittent positive pressure breathing (three). The maximum follow up was six days. Four trials only had a no intervention control; none showed any significant benefit of physiotherapy. Across all trials and interventions, average values postoperatively were: incidence of atelectasis, 15-98%; incidence of pneumonia, 0-20%; partial pressure of arterial oxygen per inspired oxygen fraction, 212-329 mm Hg; vital capacity, 37-72% of preoperative values; and forced expiratory volume in one second, 34-72%. No intervention showed superiority for any end point. For the most labour intensive intervention, continuous positive airway pressure, the average cost of labour for each patient day was 27 euro (pound 19; 32 dollars). CONCLUSIONS: The usefulness of respiratory physiotherapy for the prevention of pulmonary complications after cardiac surgery remains unproved. Large randomised trials are needed with no intervention controls, clinically relevant end points, and reasonable follow up periods.

Humans↗
PubMed2000

Invasive and minimally invasive treatment modalities for lower urinary tract symptoms: what are the relevant differences in randomised controlled trials?

OBJECTIVES: This manuscript reviews the outcomes of invasive and minimally-invasive treatments of lower urinary tract symptoms due to prostatic enlargement. METHODS: The MEDLINE database was searched for Medical Subject headings and text words including prostatic hyperplasia, treatment, surgery, thermal treatments, thermotherapy, laser, TUNA and vaportrode. Data from both randomised and non-randomised controlled trials were considered. RESULTS: All invasive treatments produce significant changes of all subjective and objective outcome parameters. The best clinical outcome has been reported for open prostatectomy followed by transurethral resection of the prostate. Complications of the different invasive techniques were difficult to analyse because of the heterogeneity of categories among different papers and lack of standard criteria. The major attraction of all minimally invasive treatment options is the low risk of bleeding requiring blood transfusions. Retrograde ejaculation was one of the most frequently reported complications for all invasive techniques. Some of the so-called less invasive treatment options appeared to be associated with a rather high incidence of minor complications somehow contradicting their minimally invasiveness. Re-treatment rate observed in patients receiving various minimally invasive treatments was always higher than following standard treatment options such as transurethral resection. CONCLUSIONS: Open prostatectomy and transurethral resection of the prostate outperform all minimally invasive treatment modalities as regards efficacy and durability of outcome. The lack of standard criteria to evaluate complications and side effects makes treatment comparisons difficult. Endorsement of the clinical research criteria proposed by the last WHO-sponsored International Consultation on BPH is strongly recommended to improve the clinical value of randomised and non-randomised controlled trials. More information is needed on long-term complications and cost-effectiveness of minimally invasive treatment modalities.

Humans↗
PubMed2002

[Adverse cardiovascular effects of postmenopausal hormone replacement therapy].

The views on the effects of postmenopausal hormone-replacement therapy (HRT) on cardiovascular disease have moved from one end of the spectrum to the other over the past decades. The presumed beneficial effects of HRT on arterial cardiovascular disease were based on observational findings and have led to the widespread use of these agents. However, recent large-scale randomised, placebo-controlled trials have demonstrated that HRT in women with a history of arterial diseases initially increases the risk of recurrent disease, while offering no benefit in the long term. Healthy postmenopausal women on HRT have an increased risk of arterial cardiovascular events compared with those taking placebo (relative risk 1.29; 95% CI: 1.02-1.63). Finally, the risk of venous thrombosis and pulmonary embolism is increased with the use of HRT. These results demonstrate that bias and confounding can play an important role in observational research and underscore the importance of randomised, placebo-controlled trials when studying the efficacy of drugs.

Cardiovascular Diseases↗
PubMed2005

Non-steroidal anti-inflammatory agents for treating cystoid macular oedema following cataract surgery.

BACKGROUND: Cystoid macular oedema (CMO) is the accumulation of fluid in the central retina (the macula) due to leakage from dilated capillaries. It is the most common cause of poor visual outcome following cataract surgery. The exact cause is unclear. Acute CMO, defined as oedema of less than four months duration, often resolve spontaneously. CMO that persists for four months or more is termed chronic CMO. Different types of non-steroidal anti-inflammatory agents (NSAIDs) are used in the treatment of CMO which may be delivered topically or systemically. OBJECTIVES: To examine the effectiveness of NSAIDs in the treatment of CMO following cataract surgery. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials - CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) on The Cochrane Library (Issue 2 2004), MEDLINE (1966 to April 2004), EMBASE (1980 to May 2004), LILACS (April 2004) and the reference lists of identified trials. We searched conference abstracts (sessions related to cataract) in ARVO 1975 to 2003. We contacted experts in the field and NSAIDs manufacturers for details on published and unpublished trials. SELECTION CRITERIA: Randomised controlled trials evaluating the effects of NSAIDs in the treatment of CMO following cataract surgery. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data. Since considerable heterogeneity was observed between studies we did not conduct meta-analyses. MAIN RESULTS: Seven trials involving a total of 266 participants were included. Four trials studied the effects of NSAIDs in chronic CMO while the other three examined the effect of NSAIDs in acute CMO. Of the studies examining chronic CMO, one study enrolled 120 participants, but the remainder had 34 or fewer participants. Four different NSAIDs were used and administered in different ways. Indomethacin was used orally and was found to be ineffective for chronic CMO in one trial. Topical fenoprofen was also found to be ineffective for chronic CMO in another small trial. Treatment with topical 0.5% ketorolac for chronic CMO was found to be effective in two trials. Three trials examined the effect of topical NSAIDs on acute CMO. The comparisons among these studies were of an NSAID to placebo, prednisolone or another NSAID. The study design differed between the studies in other important aspects thus they could not be combined in a meta-analysis. AUTHORS' CONCLUSIONS: This review found two trials which showed that topical NSAID (0.5% ketorolac tromethamine ophthalmic solution) has a positive effect on chronic CMO. However, the effects of NSAIDs in acute CMO remains unclear and needs further investigation.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2001

Topical negative pressure for treating chronic wounds.

BACKGROUND: Chronic wounds mainly affect the elderly and those with multiple health problems. Despite the use of modern dressings, some of these wounds take a long time to heal, fail to heal, or recur, causing significant pain and discomfort to the person and cost to health services. Topical negative pressure is used to promote healing of surgical wounds by using suction to drain excess fluid from wounds. OBJECTIVES: To assess the effectiveness of topical negative pressure (TNP) in treating people with chronic wounds and to identify an optimum TNP regimen. SEARCH STRATEGY: The Cochrane Wounds Group Specialised Trials Register was searched until July 2000. Experts in the field and relevant companies were contacted to enquire about ongoing and recently completed relevant trials. In addition citations within obtained papers were scrutinised to identify additional studies. SELECTION CRITERIA: All randomised controlled trials which evaluated the effectiveness of TNP in treating chronic wounds were considered. DATA COLLECTION AND ANALYSIS: Eligibility for inclusion, data extraction and details of trial quality was conducted by two reviewers independently. A narrative synthesis of results was undertaken as only two small trials fulfilled the selection criteria and they used different outcome measures. MAIN RESULTS: Two small trials with a total of 34 participants evaluated the effectiveness of TNP on chronic wound healing. Trial 1 considered patients with any type of chronic wound; Trial 2 considered patients with diabetic foot ulcers only. The trials compared TNP (as open cell foam dressing with continuous suction) for the first 48 hours with saline gauze dressings. Trial 1 reported a statistically significant reduction in wound volume at 6 weeks in favour of TNP. Trial 2 (continuous suction, followed by intermittent suction after 48 hours) reported a reduction in the number of days to healing and a reduction in wound surface area at 2 weeks in favour of TNP, - although no statistical analysis was reported. REVIEWER'S CONCLUSIONS: The two small trials provide weak evidence suggesting that TNP may be superior to saline gauze dressings in healing chronic human wounds. However, due to the small sample sizes and methodological limitations of these trials, the findings must be interpreted with extreme caution. The effect of TNP on cost, quality of life, pain and comfort was not reported. It was not possible to determine which was the optimum TNP regimen.

Bandages↗
PubMed2001

Systemic therapy for treating locoregional recurrence in women with breast cancer.

BACKGROUND: Between 10% and 35% of women with operable breast cancer will experience an isolated locoregional recurrence following their primary treatment. There is currently no good evidence that adjuvant systemic treatment is effective in this situation and there is no standard treatment for women who have such a recurrence. OBJECTIVES: To investigate whether additional systemic treatment will improve the result of local therapy in regard to relapse-free and overall survival in women with potentially curatively resected loco-regional recurrence following breast cancer, who have not had a previous or synchronous distant metastases. SEARCH STRATEGY: Searches were done, in the first half of 2001, of the specialised register of the Cochrane Breast Cancer Collaborative Review Group, The Cochrane Library, MEDLINE and EMBASE. In addition, the records of the Early Breast Cancer Trialists' Collaborative Group were checked for any relevant trials. The citations in articles reviewing the treatment of locoregional recurrence of breast cancer were checked. SELECTION CRITERIA: Randomised controlled trials or trials in which women were allocated to treatment or observation by a quasi-random process (such as alternation or date of birth) were eligible. Our aim was to consider separately women with a first incidence of isolated loco-regional recurrence in the treated breast, the chest wall or the regional lymphnode areas (except clavicular nodes) which can be resected without (R0) or with (R1) microscopically demonstrable residual disease. Women with previous or synchronous distant metastases were to be excluded from this part of the review. The second part of the review was to consider women with inoperable loco-regional recurrence and / or clavicular lymphnode involvement, regardless of previous or synchronous metastases. DATA COLLECTION AND ANALYSIS: We identified three closed studies in which there were a total of four randomised comparisons of systemic therapy versus observation for women who have received radiotherapy for loco-regional recurrence of breast cancer. One trial assessed Actinomyicin-D and randomised 32 patients in the 1960s and another randomised the same number of women to alpha-interferon versus observation in the early 1980s. The Swiss SAKK trial assessed tamoxifen for "good risk" patients and combination chemotherapy (Vincristine, Doxorubicin and Cyclophosphamide) for "poor risk" patients. It randomised 178 and 50 women respectively during 1982-1991. Where possible, data on relapse-free and overall survival were extracted for these trials and analysed using RevMan 4.1. No attempt was made to pool the results of the studies because of clinical heterogeneity and the small number of randomised patients. Three ongoing trials of chemotherapy versus observation have been identified. MAIN RESULTS: The trial of 32 women who received either radiotherapy alone or in combination with systemic administration of Actinomycin-D found that chemotherapy improved the local control rate but had no apparent effect on overall survival. The interferon trial, which also included a total of only 32 patients, showed that the addition of alpha-Interferon to local treatment of locoregional recurrent breast cancer had no apparent effect on the further course of the disease. The Swiss SAKK trial of tamoxifen (178 women randomized) found an improvement in disease-free survival but not in overall survival and no results are available for the 50 women randomized into the concurrent trial of chemotherapy. The three ongoing trials of chemotherapy have a total target accrual of nearly 2000 patients. REVIEWER'S CONCLUSIONS: This systematic review of randomised trials provides insufficient evidence to do other than conclude that the most appropriate form of practice for women with loco-regional recurrence of breast cancer is participation in randomised trials of systemic treatment versus observation.

Antineoplastic Agents↗
PubMed2002

Fibrinolytic therapy for intraventricular hemorrhage in adults.

BACKGROUND: Spontaneous or secondary intraventricular hemorrhage is a marker of poor prognosis for hemorrhagic stroke. It can cause hydrocephalus and require ventricular shunt placement, result in permanent neurological deficits or death. Fibrinolytic agents injected into the ventricular system could dissolve blood clots, increase the clearance of blood from the ventricles and hence improve outcome. OBJECTIVES: To assess the clinical efficacy and safety of thrombolytic agents administered intraventricularly in the management of intraventricular hemorrhage in adults. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (last searched February 2002). In addition, we searched the Cochrane Controlled Trials Register, MEDLINE, EMBASE, Current Contents, and International Pharmacy Abstracts to 2001. We handsearched several neurosurgery journals and the references list of articles identified. SELECTION CRITERIA: Randomised unconfounded studies comparing intraventricular fibrinolytic therapy to placebo or open control for the management of intraventricular hemorrhage in adults. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed all identified trials. Clinically significant information related to patient population, efficacy and safety were extracted and summarized. MAIN RESULTS: A total of ten studies were identified by our search strategy. Eight of them were excluded because of case series designs or retrospective control group. One quasi-randomised trial used alternate allocation and was excluded. Only one report met the review criteria for randomization. The randomised trial reported good outcome but has important design flaws resulting in a biased control group and therefore was excluded. REVIEWER'S CONCLUSIONS: There is anecdotal evidence suggesting that the intraventricular administration of fibrinolytic agents in intraventricular hemorrhage maybe of therapeutic value and safe. Thus far, there are no randomised trials of sufficient size and quality to evaluate the safety and efficacy of this treatment modality.

Adult↗
PubMed1999

Systematic review of antistaphylococcal antibiotic therapy in cystic fibrosis.

BACKGROUND: The respiratory tract in patients with cystic fibrosis is frequently colonised with Staphylococcus aureus. There is great diversity of clinical practice in this area of cystic fibrosis. A systematic review was conducted to study the evidence relating antistaphylococcal therapy to clinical outcome in patients with cystic fibrosis. METHODS: A search strategy already evaluated for the study of the epidemiology of cystic fibrosis clinical trials was used. This yielded 3188 references from which 13 clinical trials of antistaphylococcal therapy were identified. RESULTS: Substantial heterogeneity was observed between trials. In the 13 clinical trials a total of 19 antibiotics were used to assess a wide variety of outcome measures (11 clinical, six laboratory). Both intermittent and continuous treatment strategies were used. Sputum clearance of S aureus was more frequently achieved than any other beneficial outcome. A beneficial effect on pulmonary function was rarely measured or observed. Although five randomised clinical trials were identified, the extent of heterogeneity precluded the use of meta-analysis for further synthesis of information. CONCLUSIONS: Antistaphylococcal treatment achieves sputum clearance of S aureus in patients with cystic fibrosis. Prophylactic antistaphylococcal treatment in young children with cystic fibrosis is likely to be of clinical benefit. It remains to be determined whether the use of "prophylactic" versus "intermittent" antistaphylococcal therapy in cystic fibrosis is associated with improved lung function and/or chest radiographic scores, an increase in bacterial resistance, or earlier acquisition of Pseudomonas aeruginosa. A large randomised clinical trial lasting approximately two years is urgently required to address this problem.

Anti-Bacterial Agents↗
PubMed1994

Risk-benefit assessment of drug treatment to prevent coronary heart disease. Estimating the benefits of risk factor modification.

Risk factor modification to prevent the development of coronary heart disease (CHD) is a rapidly growing concern of physicians interested in disease prevention. Drug treatments to reduce hypertension and hyperlipidaemia are 2 important interventions for CHD primary prevention. The benefits of these interventions have been demonstrated in short term clinical trials by reducing the incidence of stroke and coronary events. While the short term benefits may appear modest, the long term changes in life expectancy and disease morbidity may be substantial for carefully targeted groups of patients. Computer models are therefore increasingly being used to estimate the long term benefits of risk factor modification among selected patients. A review of published CHD models demonstrates that predictions among the different models are usually consistent. Moreover, the results of randomised clinical trials can be accurately forecasted using the CHD Primary Prevention Model.

Adult↗
PubMed2001

Caspofungin.

Caspofungin is the first in a new class of antifungal agents, the glucan synthesis inhibitors, that interfere with fungal cell wall synthesis. Caspofungin exhibited in vitro and in vivo efficacy against a wide range of fungi and yeasts including Aspergillus and Candida species. A complete or partial response to caspofungin therapy was seen in 40.7% of immunocompromised adults with invasive aspergillosis who did not respond to, or did not tolerate, other antifungal agents in a noncomparative multicentre study. Caspofungin was effective in patients with oropharyngeal or oesophageal candidiasis, according to the preliminary results of 2 randomised double-blind trials. Caspofungin was generally well tolerated in a multicentre noncomparative trial involving patients with invasive aspergillosis. One or more drug-related clinical adverse effects were experienced by 13.8% of caspofungin recipients (the most common were fever, nausea, vomiting and complications associated with the vein into which caspofungin was infused). The tolerability of caspofungin appeared to be better than that of amphotericin B and similar to that of fluconazole in double-blind, randomised trials involving patients with mucosal candidiasis.

Anti-Bacterial Agents↗
PubMed2004

[Summary version of the Standards, Options and Recommendations for the use of recombinant erythropoietin (epoietin-alpha and beta, darbepoietin-alpha, EPO) in the management of anaemia in oncology - Update 2003].

UNLABELLED: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of French Cancer Centres (FNCLCC), the 20 French cancer centres, and specialists from French public universities, general hospitals and private clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and the outcome of cancer patients. The methodology is based on a literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. OBJECTIVES: To update the Standards, Options and Recommendations clinical practice guidelines for the use of recombinant erythropoietin (epoietin alpha and beta darbepoietin-alpha, EPO) in the management of anaemia in oncology. To define, on the basis of the critical appraisal of the best available evidence and expert agreement, the clinical situations in which the administration of rHuEPO is indicated, and those in which it is not indicated, except in the setting of randomised controlled trial. METHODS: The working group identified the questions requiring up-dating from the previous guideline. Medline and Embase were searched using specific search strategies from January 1999 to October 2002. Literature monitoring was performed to identify randomised clinical trials published between October 2002 to November 2003. In addition several Internet sites were searched in October 2002. RESULTS: A total of 36 new references, corresponding to 30 randomised clinical trials, were identified. The role of rHuEPO is certain when the haemoglobin concentration is below 10 g/dL, but remains uncertain when the concentration is between 10 g/dL and 12 g/dL. When the haemoglobin concentration is between 12 g/dL and 14 g/dL there is no justification to use rHuEPO to prevent anaemia, except in the setting of autologous blood transfusion programmes before major surgery. No anti-anaemic treatment is justified if the haemoglobin concentration is higher than 14 g/dL, except in the setting of a randomised clinical trial.

Anemia↗